Kornimate/medical-research-clean huggingface dataset:
atomoxetine and daw2022 on osa severity

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. in previous research atomoxetine and oxybutynin showed promising effect at reducing osa severity, however they reduced arousal threshold, one of the key traits responsible for osa. since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, daw2020, a hypnotic which prolonged the total sleep time in a previous trial in osa patients, could be a better candidate to associate with atomoxetine.

two overnight sleep studies will be performed: a drug night and a placebo night, with a month of washout between treatments. the patient will breath spontaneously (without cpap) for both nights. on the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnography for monitoring sleep, physiological variables (endotypes), and respiratory events. a history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. the drugs will be administered as follows. there will be a 3-day run in of atomoxetine 40 mg followed by atomoxetine 80 mg starting on the fourth night until the night of the study. daw2020 34 mg will be administered for 1-week to allow adequate plasma concentrations to be reached. for the sleep study, at least four hours of sleep (50% in the supine position) will be monitored to assess sleep and respiratory variables.

Eligibility criteria:
inclusion criteria: * moderate-to-severe osa (ahi ≥ 15 events/hr) exclusion criteria: * all participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements. * use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid). * use of snris/ssris. * conditions likely to affect osa physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition. * sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: * other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias. * hypersensitivity to the study drug (angioedema or urticaria) * contraindications to daw2020 * use of medications that lengthen qtc interval * hypokaliemia, hypomagnesemia, uncontrolled thyroid disease * severe claustrophobia.
unexpected abr results in patients suspected with auditory neuropathy spectrum disorder

Conditions: Auditory Neuropathy

Summary: this study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with auditory neuropathy spectrum disorder (ansd) who exhibited unusual results in audiological tests. the research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at istanbul medipol mega hospital between 2010 and 2020. these patients displayed abnormalities in their auditory brainstem response (abr) tests. the study sought to investigate patients with ansd who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.


Eligibility criteria:
inclusion criteria: * presence of wave v with cochlear microphonics exclusion criteria: * type b tympanogram
ozone and rhinovirus-induced disease in asthmatics

Conditions: Asthma

Summary: in the u.s., morbidity associated with human rhinovirus (rv) infection represents a major health problem. in asthmatics, up to 80% of asthma exacerbations are associated with upper respiratory infections. despite evidence that environmental oxidant pollutants, such as ozone, may increase the severity of viral disease, the mechanisms underlying such an effect have not been identified. this study will test the hypothesis that exposure of allergic asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing infectivity and intensifying virus-induced inflammation.

in mild asthmatics, the study will investigate: (1) if exposure to ozone will enhance the viral infective process in the nasal epithelium, (2) the effect of ozone exposure on rv-induced inflammatory gene expression, mediator release and inflammatory cell influx into the upper and lower airways, and (3) the interactive effects of ozone and rv on airway reactivity. this information will improve our understanding of the risk associated with oxidant pollutant exposure in this population of individuals in whom rv infection may represent a significant health concern.

Eligibility criteria:
subjects recruited will be non-asthmatic controls or mild allergic asthmatics using beta-agonists, mostly on an "as needed" basis. selection criteria will include good general health by medical history and physical examination, no history of smoking, and the absence of respiratory infection in the preceding 6 week period. subjects will undergo serologic testing and must have a negative test for neutralizing antibodies to rv16 to participate in all but one study of the project.

Keywords: asthma rhinovirus ozone
research of pathological imaging diagnosis of ocular tumors based on new artificial intelligence algorithm

Conditions: Melanoma (Skin); Melanoma in Situ; Nevus Eye; Sebaceous Gland Carcinoma of the Eyelid; Basal Cell Carcinoma; Squamous Cell Carcinoma in Situ; Ocular Tumor

Summary: the purpose of this study is to establish a standardized process for obtaining digital pathological image information of ocular tumors; use modern pathological techniques to obtain the co-expression information of multiple biomarkers in the pathological tissues of ocular tumors, and finally construct standardized digital ocular tumors with biomarkers pathology image database.

this study is a prospective study. patients with common and representative ocular tumors in the department of ophthalmology, peking university third hospital, will be selected and enrolled after informed consent to collect basic clinical information, preoperative blood samples, and ocular tumors obtain pathological image annotation data and genomics-related data from ocular tumor tissue specimens, use blood samples for genomics information analysis, provide multi-dimensional data for the development of artificial intelligence algorithms, and establish artificial intelligence-assisted image data for eye tumors standardize the process and establish a multi-modal ocular tumor standardized database of "clinical information-tissue samples-pathological images-genomics data". the database and the diagnosis system are correlated with each other to provide optimal image data for later machine learning and related algorithm establishment, and finally the investigators will be completed the design of a new artificial intelligence-assisted diagnosis system for eye tumors.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with eye tumors and undergoing eye tumor surgery. 2. patients sign informed consent for sample collection and sample transfer agreement, and can cooperate with long-term regular follow-up requirements. exclusion criteria: 1. patients who are unable to undergo tumor surgery or retain samples due to various reasons . 2. patients who are positive for hepatitis b, hiv, and syphilis. 3. patient compliance is poor.
randomized controlled trial of game changers

Conditions: HIV Prevention

Summary: the study is a randomized controlled trial (rct) of game changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with hiv (plwh) to be agents for hiv prevention in their social networks.

this rct of game changers, a peer-led group intervention for persons living with hiv (plwh) in uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased hiv testing, and decreased enacted hiv stigma among social network members. we will recruit 210 plwh, randomizing 105 to the intervention and 105 to an attention control. each plwh will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). all participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.

Eligibility criteria:
inclusion criteria: * age 18 years and older * hiv-positive * in hiv care at the infectious diseases institute for at least one year exclusion criteria: * participated in the prior pilot study of the intervention. * has significant cognitive impairment * health status is not sufficiently stable to reliably complete 18 month study. * does not speak luganda fluently (index participant); english or luganda fluently (social network participant) * spouse/partner or household member are enrolled as index participant in the study
collection of samples of bone marrow aspiration from patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: the study objective is to collect samples of bone marrow aspirates and peripheral blood of patients with mds for use in non-clinical research to investigate mitochondrial function sequence and effect of mitochondrial augmentation.

mitochondrial dysfunction is often associated with mds. studies have shown mitochondrial dna (mtdna) mutations in different mds subtypes; however, their role in the pathogenesis and disease progression are not yet clear. point mutations were found in various locations in the mitochondrial genome including trnas, rrnas, and mitochondrial proteins. mitochondrial fragmentation in hematopoietic stem and progenitor cells (hspc) can lead to ineffective hematopoiesis in mds, suggesting mitochondria as a therapeutic target for treating mds. mitochondria augmentation therapy (mat) is a novel cell technology where hematopoietic stem and progenitor cells (hspcs) are augmented ex vivo with mitochondria obtained from donor cells or tissue. mat is based on the demonstrated ability of isolated mitochondria to enter cells and impact mitochondrial function and metabolic activity in the recipient cells. the transfer of mitochondria from cell to cell has been demonstrated using extracellular vesicles, nanotubes, and micropinocytosis. mitochondria entering cells provide copies of normal mtdna, which can be further propagated via replication within the recipient cell and via intercellular transfer. research will include in vitro and in vivo studies with the bone marrow sample, including, among other, the following: mitochondrial augmentation of bone marrow aspiration and/or subpopulations of cells (e.g. cd34+) isolated from the bone marrow aspiration; differentiation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells into hematopoietic lineages (e.g. erythroid, megakaryocyte, etc); assays of mitochondrial content and function; assays of hematopoietic lineages; culture of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; cryopreservation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; sequencing of mitochondrial dna and nuclear dna; in vivo studies of engraftment, biodistribution and function of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells isolated from the bone marrow aspiration. research will include in vitro studies with the peripheral blood sample, including, among other, the following: immunophenotyping of peripheral blood cells and immune-related functional assays; mitochondrial content and function of peripheral blood cells.

Eligibility criteria:
inclusion criteria: 1. male or female patients of 18 years old and up. 2. suspected or previously diagnosed with myelodysplastic syndrome. 3. patient able to understand and provide voluntary written informed consent. exclusion criteria: 1. history of prior allogeneic hematopoietic stem cell transplantation, cell therapy, gene therapy.

Keywords: mitochondrial research
icg and blue dye guided sentinel lymph node biopsy in patients underwent neoadjuvant therapy

Conditions: Breast Neoplasms

Summary: the value of sentinel lymph node biopsy (slnb) in patients underwent neoadjuvant chemotherapy is controversial. lower detection rate and higher false negative rate are the main problem. the purpose of this study is to determine the detection rate and the false negative rate of slnb by indocyanine green (icg) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. this is a single arm clinical trial.

patients indicated for neoadjuvant therapy would be recruited in this study. during the surgery, slnb using the dual tracing method would be applied before axillary clearance. after the surgery, histological results of the sln and non-sln would be analysed.

Eligibility criteria:
inclusion criteria: * patients indicated for neoadjuvant therapy * have complete evaluation of the axillary status * planned for axillary clearance after neoadjuvant therapy exclusion criteria: * sensitive to iodine * inflammatory disease * patient's refusal to join the trial

Keywords: methylene blue indocyanine green neoadjuvant therapy sentinel lymph node biopsy breast neoplasms
xelox iii. xeloda in combination with eloxatin for patients with advanced or metastatic colorectal cancer

Conditions: C04.588.274.476.411.307

Summary: xelox (capecitabine and oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. chronomodulated therapy may reduce toxicity. patients will be randomized to standard xelox (capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated xelox (capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term oxaliplatin 130 mg/m² day 1 in 30 minutes). bloodsamples will be collected and frozen and later examined for potential predictive factors


Eligibility criteria:
inclusion criteria: * histological proven adenocarcinoma of the colon or rectum * measurable or non-measurable disease * performance status 0-2 * adequate renal and hepatic functions * adjuvant chemotherapy must have ended 180 days before inclusion * written informed consent prior to randomization exclusion criteria: * prior treatment with eloxatin or xeloda * peripheral neuropathy * evidence of cns metastasis * other serious illness or medical conditions (including contraindication to 5 fu e.g.: angor, myocardial infarction within 6 months) * past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer * administration of any other experimental drug under investigation within 2 weeks before randomisation * pregnant or breast feeding women * fertile patients must use adequate contraceptives

Keywords: colorectal neoplasm capecitabine (xeloda) oxaliplatin (eloxatin) advanced disease metastatic disease first-line treatment phase ii study
the effects of anodal tsdcs on chronic neuropathic pain after sci

Conditions: Neuropathic Pain; Spinal Cord Injury

Summary: the purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsdcs) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.

twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsdcs (2 ma) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). treatment order was randomly assigned. a evaluator rated the pain using the visual analogue scale for pain, patient global assessment and present pain intensity.

Eligibility criteria:
inclusion criteria: 1. cervical or upper thoracic complete motor spinal cord injury, at least 6 months after sci, 20\<=age\<90 2. neuropathic pain (lanss score \>= 12), stable chronic pain for at least the three preceding months but not over 5 years 3. score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (vas) for pain perception at the baseline/start of the treatment 4. refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months) 5. informed consent exclusion criteria: 1. patients with any clinically significant or unstable medical or progressive neurologic disorder 2. contraindication for electrial stimulation such as pacemaker implant 3. women of childbearing age or pregnancy 4. significant cognitive deficit 5. syringomyelia 6. neuropsychiatric comorbidity 7. depressive disorder (as indicated by a score of 10 greater on the beck depression inventory) 8. history of substance abuse 9. skin defect under the electrodes 10. progressive neurological disease or other secondary conditions that could impact neuropathic pain
combination chemotherapy with sildenafil plus carboplatin and paclitaxel in patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: a comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. the study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

sildenafil is one of selective phosphodiesterase type 5 inhibitors. it is used to block the degradative action of phosphodiesterase type 5 on cyclic gmp in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed stage iiib or iv non-small cell lung cancer * good performance status (ecog 0-1) * no previous treatment * adequate bone marrow, liver and renal functions * must be able to swallow tablets * provided written informed consent exclusion criteria: * severe complications or a concomitant malignancy * contraindicated sildenafil, carboplatin or taxol * inappropriate patients for entry to this study, judged by the physicians

Keywords: non-small cell lung cancer previously untreated
a study to analyze the occurrence of transformation from myelodysplastic syndrome to acute myeloid leukemia in patients with myelodysplastic syndrome who received revlimid® 5 mg capsules and who are continuing or no longer continuing revlimid treatment

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Summary: to analyze the occurrence of transformation from myelodysplastic syndrome (mds) to acute myeloid leukemia (hereinafter referred to as transformation from mds to aml) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)mds) who received revlimid® 5 mg capsules (hereinafter referred to as revlimid) and who are continuing or no longer continuing revlimid treatment. 1. planned registration period this period started on the date of initial marketing of revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qmds) patients in the all-case surveillance. 2. planned surveillance period this period started on the date of initial marketing of revlimid and will end 3 years after the last enrolled patient begins receiving revlimid.


Eligibility criteria:
inclusion criteria: * all del(5q)mds patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as aml) has not been documented at the end of the observation period of the all-case surveillance. exclusion criteria: n/a

Keywords: leukemia acute myeloid leukemia revlimid
tips for infant and parent sleep (tips)

Conditions: Sleep Deprivation

Summary: a randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.

infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. these factors may be modifiable through the use of behavioral-educational interventions. a randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. this is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.

Eligibility criteria:
inclusion criteria: * singleton baby born at ga \>37 weeks * baby 8 hours to 7 days old * mother age 16-50 years * normal, healthy infant as described in newborn examination * first time parents living in the greater toronto area * mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home exclusion criteria: * maternal or infant complications requiring prolonged hospital stay * previous stillbirth or neonatal death * maternal chronic illness * maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid) * known drug or alcohol use beyond occasional social use * smoking two packs a day or more * either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy) * mother's partner is working night shifts * mother unable to read or understand english * no telephone in the home * involvement in another research protocol involving sleep

Keywords: sleep neonates mothers behavioural intervention